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| ID | Type | Description | Link |
|---|---|---|---|
| NIH grant # 1 RC2 DA028837-01 |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo vaccine | Placebo Comparator |
| |
| NicVAX vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NicVAX vaccine | Biological | NicVAX vaccine given 6 times over 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate NicVAX as an aid to smoking cessation for long term abstinence. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate abstinence rates at multiple intervals | multiple time points | |
| Evaluate safety and immunogenicity | mulitple time points | |
| Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Nabi Biopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NicVAX Investigator | Tucson | Arizona | United States | |||
| NicVAX Investigator |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22229310 | Derived | Fahim RE, Kessler PD, Fuller SA, Kalnik MW. Nicotine vaccines. CNS Neurol Disord Drug Targets. 2011 Dec;10(8):905-15. doi: 10.2174/187152711799219343. |
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| Placebo vaccine |
| Biological |
Placebo vaccine given 6 times over 6 months |
|
| multiple time points |
| Los Angeles |
| California |
| United States |
| NicVAX Investigator | Newport Beach | California | United States |
| NicVAX Investigator | San Diego | California | United States |
| NicVAX Investigator | Denver | Colorado | United States |
| NicVAX Investigator | Farmington | Connecticut | United States |
| NicVAX Investigator | Miami | Florida | United States |
| NicVAX Investigator | St. Petersburg | Florida | United States |
| NicVAX Investigator | Boise | Idaho | United States |
| NicVAX Investigator | Lexington | Kentucky | United States |
| NicVAX Investigator | Baltimore | Maryland | United States |
| NicVAX Investigator | College Park | Maryland | United States |
| NicVAX Investigator | Boston | Massachusetts | United States |
| NicVAX Investigator | Minneapolis | Minnesota | United States |
| NicVAX Investigator | Omaha | Nebraska | United States |
| NicVAX Investigator | Rochester | New York | United States |
| NicVAX Investigator | Raleigh | North Carolina | United States |
| NicVAX Investigator | Portland | Oregon | United States |
| NicVAX Investigator | Draper | Utah | United States |
| NicVAX Investigator | Norfolk | Virginia | United States |
| NicVAX Investigator | Seattle | Washington | United States |
| NicVAX Investigator | Madison | Wisconsin | United States |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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